Vedrop 50mgml oral solution

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Tocofersolan

Предлага се от:

Orphan Europe (UK

АТС код:

A11HA08

INN (Международно Name):

Tocofersolan

дозиране:

50mg/1ml

Лекарствена форма:

Oral solution

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 09060500

Данни за продукта

OBJECT 1
VEDROP
Summary of Product Characteristics Updated 17-Nov-2017 | Orphan Europe
(UK) Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Vedrop 50 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml contains 50 mg of d-alpha-tocopherol, in the form of
tocofersolan, corresponding to 74.5 IU of
tocopherol.
Excipients:
Each ml contains 6 mg sodium methyl parahydroxybenzoate (E219), 4 mg
sodium ethyl
parahydroxybenzoate (E215) and 0.18 mmoles (4.1 mg) of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
Slightly viscous, pale yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Vedrop is indicated in vitamin E deficiency due to digestive
malabsorption in paediatric patients with
congenital chronic cholestasis or hereditary chronic cholestasis, from
birth (full term newborns) up to 18
years of age.
4.2 Posology and method of administration
The treatment with Vedrop should be initiated and supervised by a
physician experienced in the
management of patients suffering from congenital chronic cholestasis
or hereditary chronic cholestasis.
Bioavailability of vitamin E from Vedrop differs from that of other
medicinal products. The dose should
be prescribed in mg of d-alpha-tocopherol in the form of tocofersolan.
Plasma vitamin E level should be
monitored monthly for at least the first few months of therapy,
thereafter at regular intervals and the dose
adjusted accordingly if necessary.
Posology
The recommended total daily dose in paediatric patients suffering from
congenital chronic cholestasis or
hereditary chronic cholestasis is 0.34 ml/kg/day (17 mg/kg of
d-alpha-tocopherol in the form of
tocofersolan). The dose should be prescribed in ml.
The dose should be adjusted according to plasma vitamin